US5308315A - Method for determining the adequacy of dialysis - Google Patents
Method for determining the adequacy of dialysis Download PDFInfo
- Publication number
- US5308315A US5308315A US08/098,119 US9811993A US5308315A US 5308315 A US5308315 A US 5308315A US 9811993 A US9811993 A US 9811993A US 5308315 A US5308315 A US 5308315A
- Authority
- US
- United States
- Prior art keywords
- dialysis
- urea
- dialysate
- concentration
- adequacy
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1601—Control or regulation
- A61M1/1603—Regulation parameters
- A61M1/1605—Physical characteristics of the dialysate fluid
- A61M1/1609—Physical characteristics of the dialysate fluid after use, i.e. downstream of dialyser
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1601—Control or regulation
- A61M1/1619—Sampled collection of used dialysate, i.e. obviating the need for recovery of whole dialysate quantity for post-dialysis analysis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3607—Regulation parameters
- A61M1/3609—Physical characteristics of the blood, e.g. haematocrit, urea
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/04—Liquids
- A61M2202/0496—Urine
- A61M2202/0498—Urea
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/15—Detection of leaks
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3303—Using a biosensor
Definitions
- This invention relates to a method of monitoring dialysis patients to ensure that there is adequate dialysis.
- ESRD end-stage renal disease
- urea is the best marker, and currently the goal of dialysis is primarily aimed at clearance of urea.
- Urea level is subject not only to urea removal by dialysis in ESRD, but also to urea generation by protein catabolism and the level of protein intake.
- a high blood urea nitrogen (BUN) is generally accompanied by increased morbidity.
- TACurea represents an average urea concentration, and reflects exposure to the uremic toxin urea, which should generally be below 50 mg/dl for a low morbidity.
- the indices TAC urea and PCR while serving as relevant indicators of adequacy of dialysis, cannot be used to prescribe dialysis.
- the methods used for defining the dialysis prescription time dose are all based on indices derived from urea studies, which involve arguably questionable assumptions and estimates, and are indirect techniques.
- the invention is a method for determining the adequacy of dialysis, comprising determination of urea concentration in the dialysate effluent with an enzymatic urease sensor. This information is converted to arterial urea nitrogen utilizing a flow ratio correction. Arterial urea nitrogen derived from readings of an on-line monitoring sensor may be utilized as an absolute quantity, or may be used to determine the relative urea reduction ratio, as an end-point for dialysis adequacy.
- the present invention provides a method comprising utilizing electrometric measurements of urea concentration in effluent dialysate to calculate arterial blood urea nitrogen (BUN) using equations discussed below.
- Arterial BUN is a reliable index of the dialysis process if the protein catabolic rate is constant and adequate protein intake of 0.8-1.4 g/day is maintained in the steady-state.
- the method of the invention for determining the adequacy of dialysis of a patient comprises:
- the preferred method further comprises making multiple on-line measurements of the concentration of urea in said dialysate; and providing a profile of urea reduction utilizing said measurements to assess the adequacy of dialysis on an ongoing basis.
- Urea mass balance may be expressed as follows:
- BFA arterial blood flow rate in ml/min
- B A concentration of urea in arterial blood reported in urea nitrogen (mg/ml)
- BF v venous blood flow rate (ml/min)
- B v concentration of urea in venous blood (mg/ml)
- V D flow rate of dialysis fluid (ml/min)
- D U concentration of urea in dialysate (mg/ml).
- ultrafiltration Removal of fluid from the blood to the dialysate during dialysis
- ultrafiltration may be adjusted to, for example, 2.41 (about 5.31 lb) over a period of 4 hours of dialysis. This is equivalent to 2400 ml/240 minutes or 10 ml/minute.
- a urea sensor is incorporated into the artificial kidney to continuously monitor arterial BUN in the dialysate.
- Such an element incorporates a urease enzyme sensor located in the dialysate effluent stream, and as such, is distal to the extracorporeal stream so that it does not contaminate the return blood flow to the patient.
- An ideal location for the urea sensor would be at the arterial outflow, but the urease is poisoned by the presence of blood.
- the volume flow ratio the arterial blood urea can be reliably calculated. Thus, depending on how often the readings are taken, on-line and/or continuous calculations of arterial BUN may be done.
- on-line measurements of the concentration of urea in the dialysate (D U ) can be obtained, thus providing a profile of urea reduction that can be used to assess the adequacy of dialysis.
- D U dialysate
- a simple example of an on-line sampling port comprises a three-way connector to allow frequent sampling. Since sampling is from outgoing dialysate (towards the drain), contamination is not a risk factor.
- the arterial BUN calculations are used along with time of dialysis and other selected dialysis indices known in the art such as PCR and TAC urea to provide a more accurate measure of the adequacy of dialysis.
- Parameters such as KT/V and URR can be manipulated to adjust dialysis dosimetry.
- the KT/V of the delivered dialysis session may be determined by knowing the predialysis and postdialysis BUN.
- KT/V which can be calculated by multiplying the dialyzer clearance (K) as supplied by the manufacturer, which is flow dependent, by the time of dialysis, and dividing by the volume of distribution of urea, may be predicted by the arterial BUN readings obtained according to the invention.
- Readings of BUN obtained according to the invention as derived simply from direct measurements can also be used to calculate URR which also adds another parameter to assessing the adequacy of dialysis.
- the individual BUN readings provide an absolute measurement and a target value, for example, ⁇ 30 mg/dl, to end the dialysis session
- URR provides a relative measure. This is useful in some cases where initial plasma urea concentration is relatively low, such as with low protein intake, and therefore, the individual dialysis session may be ad]usted to accomplish a URR, for example, of about 65% of the target value to insure adequate dialysis.
- the invention herein thus preferably includes three main components: (1) monitoring urea in dialysate effluent using an enzymatic urease sensor; (2) converting the dialysate urea nitrogen (DUN) to the simultaneous arterial urea nitrogen (BUN) by multiplying the flow ratio correction times the DUN; and (3) utilizing the BUN derived from readings of an on-line monitoring sensor directly (arterial BUN ⁇ as an absolute quantity and the urea reduction ratio as a relative quantity, which is a new end-point defining the adequacy of dialysis and to estimate or determine other dialysis parameters as discussed above.
- DUN dialysate urea nitrogen
- BUN simultaneous arterial urea nitrogen
- a modified NOVA 12 chemistry analyzer (Nova Biomedical, Waltham, MA), with a urease enzyme-based sensor electrode was used to measure the urea concentration electrometrically in aliquots of sampled dialysate at selected time intervals.
- Plasma and dialysate determinations of urea concentration using a spectrophotometric method (Abbo&t Spectrum Analyzer, Irving, TX), were also obtained from laboratory measurements on samples obtained at the same time as the samples analyzed electrometrically with the sensor.
- the laboratory measurements of blood and dialysate urea concentrations were used as controls to validate the calculations obtained from electrometric measurements of the dialysate urea concentrations.
- BF A was kept constant at 250 ml/min while V D was increased from 300 ml/min for the first period (95 min) to 475 ml/min for the second period (80 min) and finally to 650 ml/min for the last period (65 min). Samples were taken just before changing V D .
- This protocol is another manifestation of controlling the decrease in blood urea by controlling the flow rate of the sink (in this case, the dialysate flow rate) in the hemodialysis session.
- Arterial BUN was again measured in plasma and compared to values of BUN calculated from electronic measurements.
- Table 3 shows a summary of the results. The differences between the calculated arterial BUN and the measured arterial BUN are not statistically significant at any time using the paired t-test.
Abstract
Description
Q.sub.A =Q.sub.D +Q.sub.D
BF.sub.A ×B.sub.A =(BF.sub.v ×B.sub.v)+(V.sub.D ×D.sub.U) (equation 1)
TABLE 1 ______________________________________ DUN.sup.1 Arterial BUN Arterial BUN Subject Time mg % mg % calculated.sup.2 mg % measured ______________________________________ 1 0 -- -- 63 1 14.2 42.6 46 2 11.8 35.4 41 3 10.3 30.9 31 4 9.2 27.6 28 2 0 -- -- 68 1 16.9 50.7 50 2 13.8 41.4 42 3 11.5 34.5 34 4 10.0 30.0 30 3 0 -- -- 82 1 20.2 60.6 57 2 14.4 43.2 43 3 12.1 36.3 35 4 10.0 30.0 29 4 0 -- -- 63 1 15.3 45.9 49 2 11.8 35.4 42 3 11.0 33.0 36 4 9.3 27.9 28 ______________________________________ .sup.1 Dialysate urea nitrogen measured electrometrically. .sup.2 A flow ratio of 3 was used (flow ratio = (BF.sub.V + V.sub.D)/BF.sub.A = (240 + 510)/250 = 3).
TABLE 2 ______________________________________ Sub- BF.sub.A FR.sup.2 DUN.sup.1 Art. BUN Art. BUN ject Time ml/min mg % mg % mg % calc. mg % meas. ______________________________________ 1 0 initial -- -- -- -- 1.0 150 4.33 12.8 54.6 48 1.5 200 3.50 13.5 47.3 45 2.25 250 3.00 13.5 40.5 39 3.1 300 2.67 12.7 33.9 34 3.75 350 2.43 10.9 26.9 27 2 0 initial -- -- -- -- 1.0 150 4.33 15.6 67.5 57 1.5 200 3.50 15.8 55.3 55 2.33 250 3.00 15.6 47 0 46 3.2 300 2.67 14.8 39.5 40 3.83 350 2.43 12.6 30.6 34 3 0 initial -- -- -- -- 1.0 150 4.33 16.5 71.4 54 1.45 200 3.50 15.0 52.4 47 2.15 250 3.00 14.3 42.9 42 3.0 300 2.67 13.5 36.1 32 3.67 350 2.43 12.6 30.6 25 4 0 initial -- -- -- -- 1.0 150 4.33 13.0 56.3 50 1.5 200 3.50 14.0 49.0 47 2.25 250 3.00 14.1 42.3 42 3.1 300 2.67 13.2 35.2 36 3.75 350 2.43 11.7 28.4 31 ______________________________________ .sup.1 Dialysate urea nitrogen measured electrometrically. .sup.2 Flow ratio
TABLE 3 ______________________________________ Sub- VD FR.sup.2 DUN.sup.1 Art. BUN Art. BUN ject Time ml/min mg % mg % mg % calc. mg % meas. ______________________________________ 1 0 -- -- -- -- -- 1.33 300 2.2 15.7 34.5 34 2.66 475 2.9 9.2 26.7 27 3.66 650 3.6 6.7 24.1 24 2 0 -- -- -- -- -- 1.33 300 2.2 19.7 43.3 42 2.66 475 2.9 11.2 32.5 33 3.66 650 3.6 7.7 27.7 29 3 0 -- -- -- -- -- 1.33 300 2.2 19.7 43.3 38 2.58 475 2.9 10.9 31.6 28 3.58 650 3.6 6.3 22.7 22 4 0 -- -- -- -- -- 1.33 300 2.2 19.2 42.2 41 2.58 475 2.9 11.3 32.8 34 3.58 650 3.6 6.9 24.8 28 ______________________________________ .sup.1 Dialysate urea nitrogen measured electrometrically. .sup.2 Flow ratio
Claims (2)
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
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US08/098,119 US5308315A (en) | 1993-07-27 | 1993-07-27 | Method for determining the adequacy of dialysis |
US08/196,320 US5405315A (en) | 1993-07-27 | 1994-02-15 | Method for determining adequacy of dialysis based on urea concentration |
PCT/US1994/008147 WO1995003839A1 (en) | 1993-07-27 | 1994-07-20 | Method for determining adequacy of dialysis |
Applications Claiming Priority (1)
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US08/098,119 US5308315A (en) | 1993-07-27 | 1993-07-27 | Method for determining the adequacy of dialysis |
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US08/196,320 Division US5405315A (en) | 1993-07-27 | 1994-02-15 | Method for determining adequacy of dialysis based on urea concentration |
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US5308315A true US5308315A (en) | 1994-05-03 |
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US08/098,119 Expired - Lifetime US5308315A (en) | 1993-07-27 | 1993-07-27 | Method for determining the adequacy of dialysis |
US08/196,320 Expired - Lifetime US5405315A (en) | 1993-07-27 | 1994-02-15 | Method for determining adequacy of dialysis based on urea concentration |
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US08/196,320 Expired - Lifetime US5405315A (en) | 1993-07-27 | 1994-02-15 | Method for determining adequacy of dialysis based on urea concentration |
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US5507723A (en) * | 1994-05-24 | 1996-04-16 | Baxter International, Inc. | Method and system for optimizing dialysis clearance |
WO1996033753A1 (en) * | 1995-04-28 | 1996-10-31 | Baxter International Inc. | Apparatus and method for automatically performing peritoneal equilibration tests |
US5685988A (en) * | 1993-09-15 | 1997-11-11 | Malchesky; Paul | Dialysis process and system |
US5698083A (en) * | 1995-08-18 | 1997-12-16 | Regents Of The University Of California | Chemiresistor urea sensor |
US5725773A (en) * | 1994-11-12 | 1998-03-10 | Fresenius Ag | Method and apparatus for determining the quantity of oremic toxins removed by a hemodialysis treatment |
US5788846A (en) * | 1993-03-05 | 1998-08-04 | Gambro Ab | Method of measuring the effect of a dialysis treatment |
US5858186A (en) * | 1996-12-20 | 1999-01-12 | The Regents Of The University Of California | Urea biosensor for hemodialysis monitoring |
US6561996B1 (en) * | 1998-05-19 | 2003-05-13 | Transvivo, Inc. | Apparatus and method for in vivo hemodialysis |
US20070131548A1 (en) * | 2005-12-12 | 2007-06-14 | Nova Biomedical Corporation | Disposable urea sensor and system for determining creatinine and urea nitrogen-to-creatinine ratio in a single device |
US20070161113A1 (en) * | 2006-01-06 | 2007-07-12 | Ash Stephen R | Ammonia sensor and system for use |
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US20090101577A1 (en) * | 2007-09-28 | 2009-04-23 | Fulkerson Barry N | Methods and Systems for Controlling Ultrafiltration Using Central Venous Pressure Measurements |
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US20100184198A1 (en) * | 2009-01-16 | 2010-07-22 | Joseph Russell T | Systems and Methods of Urea Processing to Reduce Sorbent Load |
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US5405315A (en) | 1995-04-11 |
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